This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

Bromfenac

Read time: 1 mins
Marketing start date: 23 Dec 2024

Summary of product characteristics


Adverse Reactions

6 ADVERSE REACTIONS The most commonly reported adverse reactions in 2 to 7% of patients were abnormal sensation in eye, conjunctival hyperemia and eye irritation (including burning/stinging) (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience The most commonly reported adverse experiences reported following use of bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache, and iritis. These events were reported in 2 to 7% of patients. 6.2 Post-Marketing Experience The following events have been identified during post-marketing use of bromfenac ophthalmic solution 0.09% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical bromfenac ophthalmic solution 0.09% or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown [ see Warnings and Precautions (5) ] .

Contraindications

4 CONTRAINDICATIONS None. None ( 4 )

Description

11 DESCRIPTION Bromfenac ophthalmic solution 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). Bromfenac sodium is designated chemically as sodium 2-amino-3-(4-bromobenzoyl) phenylacetate sesquihydrate, with an molecular formula of C 15 H 11 BrNNaO 3 • 1½H 2 O. The structural structure for bromfenac sodium is: Bromfenac sodium is a yellow or orange yellow crystalline powder. The molecular weight of bromfenac sodium is 383.17. Bromfenac ophthalmic solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3. The osmolality of bromfenac ophthalmic solution is approximately 300 mOsmol/kg. Each mL of bromfenac ophthalmic solution contains: Active: bromfenac sodium hydrate 0.1035% Preservative: benzalkonium chloride (0.05 mg/mL) Inactives: boric acid, edetate disodium (0.2 mg/mL), polysorbate 80 (1.5 mg/mL), povidone (20 mg/mL), sodium borate, sodium sulfite (2 mg/mL), sodium hydroxide to adjust pH, and water for injection. Chemical Structure

Dosage And Administration

2 DOSAGE AND ADMINISTRATION Instill one drop into the affected eye once daily beginning 1 day prior to surgery, continued on the day of surgery and through the first 14 days post-surgery (2.1) . 2.1 Recommended Dosing For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of bromfenac ophthalmic solution should be applied to the affected eye once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 14 days of the postoperative period. 2.2 Use with Other Topical Ophthalmic Medications Bromfenac ophthalmic solution may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.

Indications And Usage

1 INDICATIONS AND USAGE Bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac ophthalmic solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction (1) .

Clinical Pharmacology

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure. 12.3 Pharmacokinetics The plasma concentration of bromfenac following ocular administration of 0.09% bromfenac ophthalmic solution in humans is unknown. Based on the maximum proposed dose of one drop to the eye (0.045 mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans.

Mechanism Of Action

12.1 Mechanism of Action Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.

Pharmacokinetics

12.3 Pharmacokinetics The plasma concentration of bromfenac following ocular administration of 0.09% bromfenac ophthalmic solution in humans is unknown. Based on the maximum proposed dose of one drop to the eye (0.045 mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans.

Effective Time

20220318

Version

1

Dosage Forms And Strengths

3 DOSAGE FORMS AND STRENGTHS Topical ophthalmic solution: bromfenac 0.09%. Topical ophthalmic solution: bromfenac 0.09% (3)

Spl Product Data Elements

Bromfenac Bromfenac BROMFENAC SODIUM BROMFENAC BENZALKONIUM CHLORIDE BORIC ACID EDETATE DISODIUM POLYSORBATE 80 POVIDONE K30 SODIUM BORATE SODIUM SULFITE SODIUM HYDROXIDE WATER

Carcinogenesis And Mutagenesis And Impairment Of Fertility

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (900 times the recommended human ophthalmic dose [RHOD] of 1.67 mcg/kg in 60 kg person on a mg/kg/basis, assuming 100% absorbed) and 5 mg/kg/day (7500 times RHOD), respectively revealed no significant increases in tumor incidence. Bromfenac did not show mutagenic potential in various mutagenicity studies, including the reverse mutation, chromosomal aberration, and micronucleus tests. Bromfenac did not impair fertility when administered orally to male and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (1300 and 450 times RHOD, respectively).

Nonclinical Toxicology

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (900 times the recommended human ophthalmic dose [RHOD] of 1.67 mcg/kg in 60 kg person on a mg/kg/basis, assuming 100% absorbed) and 5 mg/kg/day (7500 times RHOD), respectively revealed no significant increases in tumor incidence. Bromfenac did not show mutagenic potential in various mutagenicity studies, including the reverse mutation, chromosomal aberration, and micronucleus tests. Bromfenac did not impair fertility when administered orally to male and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (1300 and 450 times RHOD, respectively).

Application Number

ANDA204813

Brand Name

Bromfenac

Generic Name

Bromfenac

Product Ndc

65862-789

Product Type

HUMAN PRESCRIPTION DRUG

Route

OPHTHALMIC

Package Label Principal Display Panel

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 0.09% (1.7 mL Container) NDC 65862-789-17 Bromfenac Ophthalmic Solution 0.09% For Topical Application in the Eye Once Daily AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 0.09% (1.7 mL Container)

Information For Patients

17 PATIENT COUNSELING INFORMATION 17.1 Slowed or Delayed Healing Patients should be advised of the possibility that slow or delayed healing may occur while using NSAIDs. 17.2 Sterility of Dropper Tip Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents. 17.3 Concomitant Use of Contact Lenses Contact lenses should not be worn during the use of this product. 17.4 Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart. Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India

Clinical Studies

14 CLINICAL STUDIES 14.1 Ocular Inflammation and Pain Clinical efficacy was evaluated in three randomized, double-masked, placebo-controlled trials in which subjects requiring cataract surgery were assigned to bromfenac ophthalmic solution or placebo. Patients were dosed with one drop per eye starting the day before surgery and continuing for 14 days. The primary endpoint was clearing of ocular inflammation by day 15. An additional efficacy endpoint was the number of patients who were pain free on day 1 after cataract surgery. In 2 of the 3 studies, bromfenac ophthalmic solution had statistically significant higher incidence of completely clearing inflammation (46 to 47% vs. 25 to 29%) and also had a statistically significant higher incidence of subjects that were pain free at day 1 post cataract surgery (83 to 89% vs. 51 to 71%).

Geriatric Use

8.5 Geriatric Use There is no evidence that the efficacy or safety profiles for bromfenac ophthalmic solution differ in patients 65 years of age and older compared to younger adult patients.

Nursing Mothers

8.3 Nursing Mothers Caution should be exercised when bromfenac ophthalmic solution is administered to a nursing woman.

Pediatric Use

8.4 Pediatric Use Safety and efficacy in pediatric patients below the age of 18 have not been established.

Pregnancy

8.1 Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [RHOD]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times RHOD) revealed no evidence of teratogenicity due to bromfenac. However, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. Pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects: Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided.

Use In Specific Populations

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [RHOD]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times RHOD) revealed no evidence of teratogenicity due to bromfenac. However, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. Pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects: Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided. 8.3 Nursing Mothers Caution should be exercised when bromfenac ophthalmic solution is administered to a nursing woman. 8.4 Pediatric Use Safety and efficacy in pediatric patients below the age of 18 have not been established. 8.5 Geriatric Use There is no evidence that the efficacy or safety profiles for bromfenac ophthalmic solution differ in patients 65 years of age and older compared to younger adult patients.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING Bromfenac ophthalmic solution 0.09% is a clear, yellow color solution, supplied in an opaque LDPE bottle with opaque LDPE nozzle and HDPE grey color cap as follows: 1.7 mL in 5 mL container NDC 65862-789-17 STORAGE: Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.